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Rectal Insert

FDA product code PBP · 2 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5980
Review panel
GU
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2012-10-26 – 2025-07-22

Acts as a barrier to the passage of fecal matter through the rectum.

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